NCT00206596已完成2 期
Randomized, Stratified, Double-Blind, Placebo-Controlled Phase 2 Study of Steroid-Sparing Properties of Sargramostim (Leukine) Therapy in Patients With Cortico-Dependent Crohn's Disease
Genzyme, a Sanofi Company0 个研究点目标入组 127 人开始时间: 2003年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 127
- 主要终点
- Corticosteroid-free remission
研究概览
简要总结
The purpose of this study is to evaluate the effectiveness of Leukine to decrease the need for steroid treatment for Crohn's disease.
详细描述
On 29 May 2009, Bayer began transitioning the sponsorship of this trial to Genzyme. NOTE: This study was originally posted by sponsor Berlex, Inc. Berlex, Inc. was renamed to Bayer HealthCare, Inc.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •You must have active Crohn's disease at screening and been diagnosed with Crohn's disease within 6 months at screening.
- •You must have steroid dependent disease (receiving between 10-40 mgs/day prednisone therapy for greater than 3 months prior to screening and had at least one unsuccessful attempt to reduce cortico-steroids due to worsening of disease).
- •You must be able to give yourself an injection of study drug or have another person help you give the injection.
- •You must not be pregnant and agree to use birth control if you are a sexually active male or female of childbearing potential.
排除标准
- •You may not be taking medications not allowed on this study.
- •You may not have had GI surgery or bowel obstruction in the last 6 months.
- •You may not have ever taken this drug or drugs of similar type in the past.
研究组 & 干预措施
Arm 1
Experimental
干预措施: Sargramostim (Leukine) (Drug)
Arm 2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Corticosteroid-free remission
时间窗: At the end of the study treatment
次要结局
- Steroid-free remission or response to treatment as defined by the protocol(At the end of the study treatment)
- Quality of Life using Inflammatory Bowel Disease Questionaire, SF 36 and EuroQol-derived visual scale (VAS)(At the end of the study treatment)
研究者
相似试验
终止
3 期
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseaseCrohn DiseaseNCT00295165Genzyme, a Sanofi Company33
已完成
3 期
Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn's DiseaseCrohn DiseaseNCT00206674Genzyme, a Sanofi Company286
已完成
4 期
Assessment Of Dutasteride (AVODART) In Extending The Time To Progression Of Low-Risk, Localized Prostate Cancer In MenNeoplasms, ProstateNCT00363311GlaxoSmithKline302
已完成
不适用
Steroids vs Placebo in Treatment of Tuberculous LymphadenitisTuberculous Lymphadenitis, CervicalNCT06236152Fahad Javed Awan140
终止
3 期
Efficacy of Lapaquistat Acetate on Blood Cholesterol Levels in Treating Subjects With HypercholesterolemiaHypercholesterolemiaNCT00532558Takeda657